5H-Dicyclopropa[6,7:15,16]cyclopenta[a]phenanthrene-3,5,17-triol, octadecahydro-17-(3-hydroxy-1-propynyl)-10,13-dimethyl-, (3S,5R,6R,7R,8R,9S,10R,13S,14S,15S,16S,17S)-

Short-term toxicity to aquatic invertebrates

Administrative data

Endpoint:

short-term toxicity to aquatic invertebrates

Type of information:

experimental study

Adequacy of study:

key study

Study period:

Jan 2001

Reliability:

1 (reliable without restriction)

Rationale for reliability incl. deficiencies:

guideline study

Data source

Reference

Reference Type:

study report

Title:

Unnamed

Year:

2003

Report date:

2003

Materials and methods

Test guideline

Test guideline 1

Qualifier:

according to guideline

Guideline:

EU Method C.2 (Acute Toxicity for Daphnia)

Test guideline 2

Qualifier:

according to guideline

Guideline:

OECD Guideline 202 (Daphnia sp. Acute Immobilisation Test)

Deviations:

no

GLP compliance:

yes

Test material

Test material information

Constituent 1

Reference substance name:

21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol

EC Number:

617-349-5

Cas Number:

82543-17-7

Molecular formula:

C24 H34 O4

IUPAC Name:

21a-Homo-6 alpha,7 alpha,15 alpha,16 alpha-tetrahydro-bis-3' H-cyclopropa[1',2':6,7;1'',2'':15,16]-5 beta,17 alpha-pregn-20-yne-3 beta,5,17,21a-tetrol

Test material form:

solid: bulk

Sampling and analysis

Analytical monitoring:

yes

Test solutions

Vehicle:

no

Details on test solutions:

PREPARATION AND APPLICATION OF TEST SOLUTION (especially for difficult test substances
- Method: 100 mg ZK 34506 were suspended in 1000 mL tap water, ultrasonified for approximately 30 min and constantly stirred for approxirnately 24 hours. Thereafter, the solution was filtered through a glassfibre filter.
- Eluate: no
- Differential loading: yes
- Controls: yes, test medium control

Test organisms

Test organisms (species):

Daphnia magna

Details on test organisms:

TEST ORGANISM
- Common name: water flea
- Age at study initiation (mean and range, SD): < 24 h
- Source: Schering AG, Experimental Toxicology, Berlin, Germany
- Age of parental stock (mean and range, SD):
- Feeding during test: none
- Holding conditions: Holding: Parent animals were kept in glass vessels in water ofthe same quality and temperature as under experimental conditions. The animals were continuously fed with a laboratory culture of microalgae, e.g. Chlorella
vulgaris.

Study design

Test type:

static

Water media type:

freshwater

Limit test:

yes

Total exposure duration:

48 h

Test conditions

Test temperature:

20.2 - 20.5 °C

pH:

The pH varied between 7.7 at the beginning and 8.5 at the end of the test.

Dissolved oxygen:

7.2 - 8.9 mg/L

Nominal and measured concentrations:

The mean concentration of the test solution was 101.2 mg/L.

Details on test conditions:

TEST SYSTEM
- Test vessel: 100 mL test vessels
- Volume of solution: 50 mL
- Aeration: no
- No. of organisms per vessel: 5
- No. of vessels per concentration (replicates): 4
- No. of vessels per control (replicates): 4

TEST MEDIUM / WATER PARAMETERS
- Source/preparation of dilution water: according to guideline

OTHER TEST CONDITIONS
- Photoperiod: 12 h light/ 12 h darkness

EFFECT PARAMETERS MEASURED (with observation intervals if applicable)
- Mobility after 24 and 48 h

Reference substance (positive control):

no

Results and discussion

Effect concentrations

Key result

Duration:

48 h

Dose descriptor:

EC50

Effect conc.:

> 100 mg/L

Nominal / measured:

nominal

Conc. based on:

test mat.

Basis for effect:

mobility

Applicant's summary and conclusion

Validity criteria fulfilled:

yes

Conclusions:

The EC50/48 hours of Trihydroxypropinol (ZK 34506) to Daphnia magna is expected to be higher than 100 mg/L.
Accordingly, Trihydroxypropinol is not toxic to Daphnia magna.

Executive summary:

The purpose of the study was to determine the acute toxicity (immobilization, EC50 / 48 hours) of Trihydroxypropinol (ZK 34506) with Daphnia magna in order to evaluate the aquatic toxicity. Trihydroxypropinol is an intermediate of the synthesis of drospirenone. The study was conducted as a limit test according to the following guidelines of the OECD, no 202, and the EC guideline Part 2 - Testing Methods, Part C.2.

20 juvenile Daphnia magna were used for the test solution of Trihydroxypropinol and 20 for the tap water control. The Daphnia were exposed for a period of 48 hours under static conditions. Immobilization was recorded at 24 hours and 48 hours.

No immobilization of Daphnia could be observed. The EC50/48 hours of Trihydroxypropinol to Daphnia magna is expected to be higher than 100 mg/L. Accordingly, Trihydroxypropinol is not toxic to Daphnia magna.